Viewing Study NCT06193967


Ignite Creation Date: 2025-12-25 @ 12:54 AM
Ignite Modification Date: 2025-12-26 @ 1:46 PM
Study NCT ID: NCT06193967
Status: COMPLETED
Last Update Posted: 2025-12-03
First Post: 2023-12-21
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Enhancing Child Dietary Self-monitoring
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hraynor@utk.edu', 'phone': '865-974-9126', 'title': 'Dr. Hollie Raynor', 'phoneExt': '1', 'organization': 'University of Tennessee, Knoxville'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Children: BASIC', 'description': "Children will be asked to track their intake of fruits, vegetables, sweet and salty snack foods, and sugary drinks in the web-based dietary self-monitoring (DSM) log for 4 weeks. Each child will be provided with a personal URL to access their log, which can be accessed from any internet-capable device (computer, phone, etc.). Caregivers will be asked to review their child's log each day and complete a caregiver check-in in the DSM log.", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Children: PRAISE', 'description': "In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in.\n\nCaregiver Praise: Caregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Children: GAME', 'description': "In addition to the conditions of the BASIC group, the child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.\n\nGamification: DSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Children: PRAISE+GAME', 'description': "In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in. The child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.\n\nCaregiver Praise: Caregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement\n\nGamification: DSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors", 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Parent: BASIC', 'description': "Children will be asked to track their intake of fruits, vegetables, sweet and salty snack foods, and sugary drinks in the web-based dietary self-monitoring (DSM) log for 4 weeks. Each child will be provided with a personal URL to access their log, which can be accessed from any internet-capable device (computer, phone, etc.). Caregivers will be asked to review their child's log each day and complete a caregiver check-in in the DSM log.", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Parent: PRAISE', 'description': "In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in.\n\nCaregiver Praise: Caregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Parent: GAME', 'description': "In addition to the conditions of the BASIC group, the child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.\n\nGamification: DSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Parent: PRAISE+GAME', 'description': "In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in. The child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.\n\nCaregiver Praise: Caregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement\n\nGamification: DSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors", 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dietary Self-monitoring Frequency, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '22.0', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '25.3', 'spread': '1.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A standard alpha level of ≥ 0.05 was used to determine statistical significance.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM frequency (number of days with tracking). A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}, {'pValue': '>0.05', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM frequency (number of days with tracking). A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'I.e., number of days with any logging. DSM frequency has been shown to predict success in family-based based childhood overweight and obesity programs. A day will be counted as "tracked" if any food or beverage is logged on that day or, if no food or beverage is logged, the "Logging Complete" button is clicked.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'PRIMARY', 'title': 'Dietary Self-monitoring Frequency, Weekly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '6.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '6.9', 'spread': '0.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '6.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '6.6', 'spread': '0.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '5.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '0.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '5.4', 'spread': '0.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'A standard alpha level of ≥ 0.05 was used to determine statistical significance.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Linear mixed-factor ANOVA was used with between-subject factors of praise and gamification status, a within-subject factor of time (week), and a dependent variable of DSM frequency.\n\nResults reflect outcomes for main effect of time.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'I.e., number of days with any logging per week', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'PRIMARY', 'title': 'Proportion of Items Tracked on Day of Intake, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '0.70', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '0.73', 'spread': '0.06', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A standard alpha level of ≥ 0.05 was used to determine statistical significance.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM timing (proportion of items tracked on day of intake). A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}, {'pValue': '>0.05', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM timing (proportion of items tracked on day of intake). A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Proportion of food/beverage items that were tracked on the day of intake across the 4-week DSM period', 'unitOfMeasure': 'proportion of items tracked', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'PRIMARY', 'title': 'Proportion of Items Tracked on Day of Intake, Weekly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '0.82', 'spread': '0.06', 'groupId': 'OG002'}, {'value': '0.84', 'spread': '0.07', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '0.68', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '0.71', 'spread': '0.09', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '0.66', 'spread': '0.09', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '0.59', 'spread': '0.13', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'A standard alpha level of ≥ 0.05 was used to determine statistical significance.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Linear mixed-factor ANOVA was used with between-subject factors of praise and gamification status, a within-subject factor of time (week), and a dependent variable of DSM timing (Proportion of Items Tracked on Day of Intake).\n\nResults reflect outcomes for main effect of time.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Proportion of food/beverage items that were tracked on the day of intake by week', 'unitOfMeasure': 'proportion of items tracked', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'PRIMARY', 'title': 'Number of Logging Sessions, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '22.4', 'spread': '2.8', 'groupId': 'OG002'}, {'value': '23.7', 'spread': '2.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A standard alpha level of ≥ 0.05 was used to determine statistical significance.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM timing (number of logging sessions). A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}, {'pValue': '>0.05', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM timing (number of logging sessions). A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The average number of logging sessions per day. Sessions were considered distinct tracking events if they occurred \\>15 minutes apart.', 'unitOfMeasure': 'logging sessions/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'PRIMARY', 'title': 'Number of Logging Sessions, Weekly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '7.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '7.1', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '8.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '6.1', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '5.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '0.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'A standard alpha level of ≥ 0.05 was used to determine statistical significance.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Linear mixed-factor ANOVA was used with between-subject factors of praise and gamification status, a within-subject factor of time (week), and a dependent variable of DSM timing (number of loging sessions).\n\nResults reflect outcomes for main effect of time.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The average number of logging sessions per day. Sessions were considered distinct tracking events if they occurred \\>15 minutes apart.', 'unitOfMeasure': 'logging sessions/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'SECONDARY', 'title': 'Child Intrinsic Motivation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'title': 'Interest/enjoyment', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '5.2', 'spread': '0.6', 'groupId': 'OG003'}]}]}, {'title': 'Perceived competence', 'categories': [{'measurements': [{'value': '5.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '0.4', 'groupId': 'OG003'}]}]}, {'title': 'Perceived choice', 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '0.4', 'groupId': 'OG003'}]}]}, {'title': 'Pressure/tension', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '0.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on motivation, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dependent variable of intrinsic motivation at follow-up, and a covariate of intrinsic motivation at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}, {'pValue': '>0.05', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on motivation, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dependent variable of intrinsic motivation at follow-up, and a covariate of intrinsic motivation at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Gamification and caregiver praise may differentially affect child motivation to engage in DSM. The Task Evaluation Questionnaire of the Intrinsic Motivation Inventory (IMI) was used to determine whether there were differences in pre-post changes in child intrinsic motivation. This questionnaire consists of 22 items and utilizes a 5-point Likert scale (not at all true to very true) to assess interest/enjoyment, perceived choice, perceived competence, and pressure/tension. At baseline, the measure was administered after the child has practiced using the log with the research assistant so that he or she had some familiarity with the behavior before completing the measure.\n\nScales range from 1 to 7, with a higher score indicating a greater degree of the respective motivation subdomain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'SECONDARY', 'title': 'Child Motivation to Change Eating Behaviors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '30.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '30.1', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '31.2', 'spread': '0.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A standard alpha level of ≥ 0.05 was used to determine statistical significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on motivation, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dependent variable of scores for child motivation to change eating behaviors at follow-up, and a covariate of baseline scores. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}, {'pValue': '>0.05', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on motivation, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dependent variable of scores for child motivation to change eating behaviors at follow-up, and a covariate of baseline scores. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Child's motivation to change eating habits will be measured, as this may influence engagement in DSM. Children will be asked to complete the 8-item diet subscale of the Motivation to Exercise and Diet Questionnaire-Adapted for Children (MED-C), which is based on self-determination theory. The MED-C diet subscale utilizes a 5-point Likert scale (never to always) and includes 5 items related to motivation and 3 items related to self-determination theory needs (autonomy, competence, relatedness). This validity of the questionnaire has been tested in children aged 7 to 11 years.\n\nScale ranges from 0 to 32, with a higher score indicating greater motivation to change eating habits.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'SECONDARY', 'title': 'Child Dietary Intake, Fruit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}, {'pValue': '>0.05', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'A standard alpha level of ≥ 0.05 was used to determine statistical significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The act of self-monitoring a behavior may result in reactivity, or improvements in the monitored behavior in the absence of other intervention. Thus, child dietary intake will also be assessed at baseline and follow-up using the Block Food Screener for Ages 2-17 2007. The instrument asks about intake in the "last week" and focuses on take of fruit, fruit juices, vegetables, potatoes (including French fries), whole grains, animal-based proteins, dairy, legumes, saturated fat, added sugars (in sweetened cereals, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.', 'unitOfMeasure': 'cup equivalents', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'SECONDARY', 'title': 'Child Dietary Intake, Vegetables Excluding Potatoes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'categories': [{'measurements': [{'value': '.6', 'spread': '.1', 'groupId': 'OG000'}, {'value': '.6', 'spread': '.1', 'groupId': 'OG001'}, {'value': '.4', 'spread': '.1', 'groupId': 'OG002'}, {'value': '.8', 'spread': '.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A standard alpha level of ≥ 0.05 was used to determine statistical significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}, {'pValue': '0.03', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The act of self-monitoring a behavior may result in reactivity, or improvements in the monitored behavior in the absence of other intervention. Thus, child dietary intake will also be assessed at baseline and follow-up using the Block Food Screener for Ages 2-17 2007. The instrument asks about intake in the "last week" and focuses on take of fruit, fruit juices, vegetables, potatoes (including French fries), whole grains, animal-based proteins, dairy, legumes, saturated fat, added sugars (in sweetened cereals, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.', 'unitOfMeasure': 'cup equivalents', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'SECONDARY', 'title': 'Child Dietary Intake, Potatoes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'categories': [{'measurements': [{'value': '.2', 'spread': '.04', 'groupId': 'OG000'}, {'value': '.2', 'spread': '.04', 'groupId': 'OG001'}, {'value': '.1', 'spread': '.03', 'groupId': 'OG002'}, {'value': '.3', 'spread': '.04', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}, {'pValue': '0.02', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The act of self-monitoring a behavior may result in reactivity, or improvements in the monitored behavior in the absence of other intervention. Thus, child dietary intake will also be assessed at baseline and follow-up using the Block Food Screener for Ages 2-17 2007. The instrument asks about intake in the "last week" and focuses on take of fruit, fruit juices, vegetables, potatoes (including French fries), whole grains, animal-based proteins, dairy, legumes, saturated fat, added sugars (in sweetened cereals, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.', 'unitOfMeasure': 'cup equivalents', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'SECONDARY', 'title': 'Child Dietary Intake, Sweet & Salty Snack Foods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '46.5', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '38.3', 'spread': '8.0', 'groupId': 'OG002'}, {'value': '44.7', 'spread': '8.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}, {'pValue': '>0.05', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The act of self-monitoring a behavior may result in reactivity, or improvements in the monitored behavior in the absence of other intervention. Thus, child dietary intake will also be assessed at baseline and follow-up using the Block Food Screener for Ages 2-17 2007. The instrument asks about intake in the "last week" and focuses on take of fruit, fruit juices, vegetables, potatoes (including French fries), whole grains, animal-based proteins, dairy, legumes, saturated fat, added sugars (in sweetened cereals, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}, {'type': 'SECONDARY', 'title': 'Child Dietary Intake, Sugar-sweetened Beverages', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Caregiver Praise', 'description': 'Children not assigned to receive caregiver praise (i.e., participants from BASIC and GAME)'}, {'id': 'OG001', 'title': 'Caregiver Praise', 'description': 'Children assigned to receive caregiver praise (i.e., participants from PRAISE and PRAISE+GAME)'}, {'id': 'OG002', 'title': 'No Gamification', 'description': 'Children not assigned to receive gamification (i.e., participants from BASIC and PRAISE)'}, {'id': 'OG003', 'title': 'Gamification', 'description': 'Children assigned to receive gamification (i.e., participants from GAME and PRAISE+GAME)'}], 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '26.0', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '33.2', 'spread': '7.7', 'groupId': 'OG002'}, {'value': '20.9', 'spread': '8.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}, {'pValue': '>0.05', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\\*caregiver praise interaction term was also included in the model to test for interactive effects.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The act of self-monitoring a behavior may result in reactivity, or improvements in the monitored behavior in the absence of other intervention. Thus, child dietary intake will also be assessed at baseline and follow-up using the Block Food Screener for Ages 2-17 2007. The instrument asks about intake in the "last week" and focuses on take of fruit, fruit juices, vegetables, potatoes (including French fries), whole grains, animal-based proteins, dairy, legumes, saturated fat, added sugars (in sweetened cereals, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.', 'unitOfMeasure': 'kilocalories', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads were randomized by condition (BASIC, PRAISE, GAME, or PRAISE+GAME). However, factorial analysis was used to calculate the main effects of the independent variables, i.e. assignment to praise and assignment to gamification. Therefore, the table presents results for the same 19 enrolled children twice: 1) as assigned to praise versus not assigned to praise and 2) as assigned to gamification versus not assigned to gamification.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BASIC', 'description': "Children will be asked to track their intake of fruits, vegetables, sweet and salty snack foods, and sugary drinks in the web-based dietary self-monitoring (DSM) log for 4 weeks. Each child will be provided with a personal URL to access their log, which can be accessed from any internet-capable device (computer, phone, etc.). Caregivers will be asked to review their child's log each day and complete a caregiver check-in in the DSM log."}, {'id': 'FG001', 'title': 'PRAISE', 'description': "In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in.\n\nCaregiver Praise: Caregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement"}, {'id': 'FG002', 'title': 'GAME', 'description': "In addition to the conditions of the BASIC group, the child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.\n\nGamification: DSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors"}, {'id': 'FG003', 'title': 'PRAISE+GAME', 'description': "In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in. The child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.\n\nCaregiver Praise: Caregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement\n\nGamification: DSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Dyads', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Children', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Caregivers', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'comment': 'Dyads', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Numbers for Protocol Enrollment, Number Started, and Number Completed reflect dyads'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'BASIC', 'description': "Children will be asked to track their intake of fruits, vegetables, sweet and salty snack foods, and sugary drinks in the web-based dietary self-monitoring (DSM) log for 4 weeks. Each child will be provided with a personal URL to access their log, which can be accessed from any internet-capable device (computer, phone, etc.). Caregivers will be asked to review their child's log each day and complete a caregiver check-in in the DSM log."}, {'id': 'BG001', 'title': 'PRAISE', 'description': "In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in.\n\nCaregiver Praise: Caregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement"}, {'id': 'BG002', 'title': 'GAME', 'description': "In addition to the conditions of the BASIC group, the child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.\n\nGamification: DSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors"}, {'id': 'BG003', 'title': 'PRAISE+GAME', 'description': "In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in. The child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.\n\nCaregiver Praise: Caregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement\n\nGamification: DSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors"}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '9.2', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '10.8', 'spread': '1.3', 'groupId': 'BG002'}, {'value': '9.3', 'spread': '1.3', 'groupId': 'BG003'}, {'value': '9.1', 'spread': '2.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Child age', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Child only measure'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '43.0', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '43.0', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '44.0', 'spread': '3.6', 'groupId': 'BG002'}, {'value': '41.0', 'spread': '6.7', 'groupId': 'BG003'}, {'value': '42.8', 'spread': '4.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Caregiver age', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Caregiver only measure'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Child sex', 'unitOfMeasure': 'Participants', 'populationDescription': 'Child only measure'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregiver sex', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregiver only measure'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Child ethnicity', 'unitOfMeasure': 'Participants', 'populationDescription': 'Child only measure'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregiver ethnicity', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregiver only measure'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Child race', 'unitOfMeasure': 'Participants', 'populationDescription': 'Child only measure'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregiver race', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregiver only measure'}, {'title': 'Child BMI Percentile', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '37.0', 'spread': '17.8', 'groupId': 'BG000'}, {'value': '76.8', 'spread': '30.9', 'groupId': 'BG001'}, {'value': '68.6', 'spread': '33.7', 'groupId': 'BG002'}, {'value': '60.0', 'spread': '31.8', 'groupId': 'BG003'}, {'value': '60.6', 'spread': '30.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentile', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Child only measure'}, {'title': 'Caregiver marital status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Married', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Never married', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Refused to answer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregiver only measure'}, {'title': 'Caregiver education level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Grade 12 or GED (high school graduate)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'College 1 year to 3 years (some college or technical school)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'College 4 years or more (college graduate)', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregiver only measure'}, {'title': 'Household income', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Less than $10,000', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '$10,000 to $19,999', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '$20,000 to $29,999', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': '$30,000 to $39,999', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '$40,000 to $49,999', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '$50,000 to $59,999', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '$60,000 to $69,999', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': '$70,000 to $79,999', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': '$80,000 to $89,999', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '$90,000 to $99,999', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '$100,000 to $149,999', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': '$150,000 or more', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregiver only measure'}, {'title': 'Caregiver Parenting Styles & Dimensions Questionnaire (PSDQ) score', 'classes': [{'title': 'Authoritative domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '4.2', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '0.2', 'groupId': 'BG002'}, {'value': '4.2', 'spread': '0.3', 'groupId': 'BG003'}, {'value': '4.1', 'spread': '0.3', 'groupId': 'BG004'}]}]}, {'title': 'Authoritarian domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '1.8', 'spread': '0.3', 'groupId': 'BG002'}, {'value': '1.7', 'spread': '0.5', 'groupId': 'BG003'}, {'value': '1.6', 'spread': '0.3', 'groupId': 'BG004'}]}]}, {'title': 'Permissive domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '2.0', 'spread': '0.3', 'groupId': 'BG003'}, {'value': '2.2', 'spread': '0.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The scale for each domain is 1 to 5. A lower score indicates less adherence to the respective parenting style, while a higher score indicates greater adherence to the respective parenting style.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Caregiver only measure'}], 'populationDescription': 'Numbers include both child and caregiver participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-07', 'size': 147291, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-06T20:44', 'hasProtocol': True}, {'date': '2024-04-17', 'size': 130200, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-06T20:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '2 x 2 factorial design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2023-12-21', 'resultsFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2023-12-21', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-01', 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary Self-monitoring Frequency, Overall', 'timeFrame': '4 weeks', 'description': 'I.e., number of days with any logging. DSM frequency has been shown to predict success in family-based based childhood overweight and obesity programs. A day will be counted as "tracked" if any food or beverage is logged on that day or, if no food or beverage is logged, the "Logging Complete" button is clicked.'}, {'measure': 'Dietary Self-monitoring Frequency, Weekly', 'timeFrame': '4 weeks', 'description': 'I.e., number of days with any logging per week'}, {'measure': 'Proportion of Items Tracked on Day of Intake, Overall', 'timeFrame': '4 weeks', 'description': 'Proportion of food/beverage items that were tracked on the day of intake across the 4-week DSM period'}, {'measure': 'Proportion of Items Tracked on Day of Intake, Weekly', 'timeFrame': '4 weeks', 'description': 'Proportion of food/beverage items that were tracked on the day of intake by week'}, {'measure': 'Number of Logging Sessions, Overall', 'timeFrame': '4 weeks', 'description': 'The average number of logging sessions per day. Sessions were considered distinct tracking events if they occurred \\>15 minutes apart.'}, {'measure': 'Number of Logging Sessions, Weekly', 'timeFrame': '4 weeks', 'description': 'The average number of logging sessions per day. Sessions were considered distinct tracking events if they occurred \\>15 minutes apart.'}], 'secondaryOutcomes': [{'measure': 'Child Intrinsic Motivation', 'timeFrame': '4 weeks', 'description': 'Gamification and caregiver praise may differentially affect child motivation to engage in DSM. The Task Evaluation Questionnaire of the Intrinsic Motivation Inventory (IMI) was used to determine whether there were differences in pre-post changes in child intrinsic motivation. This questionnaire consists of 22 items and utilizes a 5-point Likert scale (not at all true to very true) to assess interest/enjoyment, perceived choice, perceived competence, and pressure/tension. At baseline, the measure was administered after the child has practiced using the log with the research assistant so that he or she had some familiarity with the behavior before completing the measure.\n\nScales range from 1 to 7, with a higher score indicating a greater degree of the respective motivation subdomain.'}, {'measure': 'Child Motivation to Change Eating Behaviors', 'timeFrame': '4 weeks', 'description': "Child's motivation to change eating habits will be measured, as this may influence engagement in DSM. Children will be asked to complete the 8-item diet subscale of the Motivation to Exercise and Diet Questionnaire-Adapted for Children (MED-C), which is based on self-determination theory. The MED-C diet subscale utilizes a 5-point Likert scale (never to always) and includes 5 items related to motivation and 3 items related to self-determination theory needs (autonomy, competence, relatedness). This validity of the questionnaire has been tested in children aged 7 to 11 years.\n\nScale ranges from 0 to 32, with a higher score indicating greater motivation to change eating habits."}, {'measure': 'Child Dietary Intake, Fruit', 'timeFrame': '4 weeks', 'description': 'The act of self-monitoring a behavior may result in reactivity, or improvements in the monitored behavior in the absence of other intervention. Thus, child dietary intake will also be assessed at baseline and follow-up using the Block Food Screener for Ages 2-17 2007. The instrument asks about intake in the "last week" and focuses on take of fruit, fruit juices, vegetables, potatoes (including French fries), whole grains, animal-based proteins, dairy, legumes, saturated fat, added sugars (in sweetened cereals, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.'}, {'measure': 'Child Dietary Intake, Vegetables Excluding Potatoes', 'timeFrame': '4 weeks', 'description': 'The act of self-monitoring a behavior may result in reactivity, or improvements in the monitored behavior in the absence of other intervention. Thus, child dietary intake will also be assessed at baseline and follow-up using the Block Food Screener for Ages 2-17 2007. The instrument asks about intake in the "last week" and focuses on take of fruit, fruit juices, vegetables, potatoes (including French fries), whole grains, animal-based proteins, dairy, legumes, saturated fat, added sugars (in sweetened cereals, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.'}, {'measure': 'Child Dietary Intake, Potatoes', 'timeFrame': '4 weeks', 'description': 'The act of self-monitoring a behavior may result in reactivity, or improvements in the monitored behavior in the absence of other intervention. Thus, child dietary intake will also be assessed at baseline and follow-up using the Block Food Screener for Ages 2-17 2007. The instrument asks about intake in the "last week" and focuses on take of fruit, fruit juices, vegetables, potatoes (including French fries), whole grains, animal-based proteins, dairy, legumes, saturated fat, added sugars (in sweetened cereals, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.'}, {'measure': 'Child Dietary Intake, Sweet & Salty Snack Foods', 'timeFrame': '4 weeks', 'description': 'The act of self-monitoring a behavior may result in reactivity, or improvements in the monitored behavior in the absence of other intervention. Thus, child dietary intake will also be assessed at baseline and follow-up using the Block Food Screener for Ages 2-17 2007. The instrument asks about intake in the "last week" and focuses on take of fruit, fruit juices, vegetables, potatoes (including French fries), whole grains, animal-based proteins, dairy, legumes, saturated fat, added sugars (in sweetened cereals, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.'}, {'measure': 'Child Dietary Intake, Sugar-sweetened Beverages', 'timeFrame': '4 weeks', 'description': 'The act of self-monitoring a behavior may result in reactivity, or improvements in the monitored behavior in the absence of other intervention. Thus, child dietary intake will also be assessed at baseline and follow-up using the Block Food Screener for Ages 2-17 2007. The instrument asks about intake in the "last week" and focuses on take of fruit, fruit juices, vegetables, potatoes (including French fries), whole grains, animal-based proteins, dairy, legumes, saturated fat, added sugars (in sweetened cereals, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutrition, Healthy']}, 'referencesModule': {'references': [{'pmid': '16775083', 'type': 'BACKGROUND', 'citation': 'Germann JN, Kirschenbaum DS, Rich BH. Child and parental self-monitoring as determinants of success in the treatment of morbid obesity in low-income minority children. J Pediatr Psychol. 2007 Jan-Feb;32(1):111-21. doi: 10.1093/jpepsy/jsl007. Epub 2006 Jun 14.'}, {'pmid': '21722068', 'type': 'BACKGROUND', 'citation': 'Mockus DS, Macera CA, Wingard DL, Peddecord M, Thomas RG, Wilfley DE. Dietary self-monitoring and its impact on weight loss in overweight children. Int J Pediatr Obes. 2011 Aug;6(3-4):197-205. doi: 10.3109/17477166.2011.590196. Epub 2011 Jul 4.'}, {'type': 'BACKGROUND', 'citation': "Saelens BE, McGrath AM. Self-monitoring adherence and adolescent weight control efficacy. Children's Health Care. 2003;32(2):137-152."}, {'pmid': '24124398', 'type': 'BACKGROUND', 'citation': 'Dalle Grave R, Centis E, Marzocchi R, El Ghoch M, Marchesini G. Major factors for facilitating change in behavioral strategies to reduce obesity. Psychol Res Behav Manag. 2013 Oct 3;6:101-10. doi: 10.2147/PRBM.S40460.'}, {'pmid': '32052993', 'type': 'BACKGROUND', 'citation': 'Guideline Development Panel for Treatment of Obesity, American Psychological Association. Summary of the clinical practice guideline for multicomponent behavioral treatment of obesity and overweight in children and adolescents. Am Psychol. 2020 Feb-Mar;75(2):178-188. doi: 10.1037/amp0000530.'}, {'type': 'BACKGROUND', 'citation': 'Favell JE. The power of positive reinforcement: a handbook of behavior modification. Charles C Thomas; 1977.'}, {'pmid': '33955110', 'type': 'BACKGROUND', 'citation': 'Griffiths LA, Douglas SM, Raynor HA. The role of structure in dietary approaches for the treatment of pediatric overweight and obesity: A critical review. Obes Rev. 2021 Sep;22(9):e13266. doi: 10.1111/obr.13266. Epub 2021 May 5.'}, {'pmid': '22283380', 'type': 'BACKGROUND', 'citation': 'Henggeler SW, Sheidow AJ. Empirically supported family-based treatments for conduct disorder and delinquency in adolescents. J Marital Fam Ther. 2012 Jan;38(1):30-58. doi: 10.1111/j.1752-0606.2011.00244.x. Epub 2011 Sep 20.'}, {'type': 'BACKGROUND', 'citation': 'Freeman JB, Garcia AM. Family based treatment for young children with OCD: therapist guide. Oxford University Press; 2008.'}, {'type': 'BACKGROUND', 'citation': 'Garett R, Young SD. Health care gamification: a study of game mechanics and elements. Technology, Knowledge and Learning. 2019;24(3):341-353.'}, {'pmid': '15320998', 'type': 'BACKGROUND', 'citation': 'Kumar VS, Wentzell KJ, Mikkelsen T, Pentland A, Laffel LM. The DAILY (Daily Automated Intensive Log for Youth) trial: a wireless, portable system to improve adherence and glycemic control in youth with diabetes. Diabetes Technol Ther. 2004 Aug;6(4):445-53. doi: 10.1089/1520915041705893.'}, {'pmid': '22564332', 'type': 'BACKGROUND', 'citation': 'Cafazzo JA, Casselman M, Hamming N, Katzman DK, Palmert MR. Design of an mHealth app for the self-management of adolescent type 1 diabetes: a pilot study. J Med Internet Res. 2012 May 8;14(3):e70. doi: 10.2196/jmir.2058.'}, {'pmid': '21699639', 'type': 'BACKGROUND', 'citation': 'Klingensmith GJ, Aisenberg J, Kaufman F, Halvorson M, Cruz E, Riordan ME, Varma C, Pardo S, Viggiani MT, Wallace JF, Schachner HC, Bailey T. Evaluation of a combined blood glucose monitoring and gaming system (Didget(R)) for motivation in children, adolescents, and young adults with type 1 diabetes. Pediatr Diabetes. 2013 Aug;14(5):350-7. doi: 10.1111/j.1399-5448.2011.00791.x. Epub 2011 Jun 23.'}, {'pmid': '27155609', 'type': 'BACKGROUND', 'citation': 'Swartwout E, El-Zein A, Deyo P, Sweenie R, Streisand R. Use of Gaming in Self-Management of Diabetes in Teens. Curr Diab Rep. 2016 Jul;16(7):59. doi: 10.1007/s11892-016-0754-2.'}, {'pmid': '31169427', 'type': 'BACKGROUND', 'citation': 'Debong F, Mayer H, Kober J. Real-World Assessments of mySugr Mobile Health App. Diabetes Technol Ther. 2019 Jun;21(S2):S235-S240. doi: 10.1089/dia.2019.0019.'}, {'pmid': '10589297', 'type': 'BACKGROUND', 'citation': 'Deci EL, Koestner R, Ryan RM. A meta-analytic review of experiments examining the effects of extrinsic rewards on intrinsic motivation. Psychol Bull. 1999 Nov;125(6):627-68; discussion 692-700. doi: 10.1037/0033-2909.125.6.627.'}, {'type': 'BACKGROUND', 'citation': 'Mekler ED, Brühlmann F, Opwis K, Tuch AN. Do points, levels and leaderboards harm intrinsic motivation? An empirical analysis of common gamification elements. 2013:66-73.'}, {'type': 'BACKGROUND', 'citation': 'Linehan C, Kirman B, Roche B. Gamification as behavioral psychology. The Gameful world: Approaches, Issues, Applications. MIT Press; 2015:81-105.'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial was to test the preliminary efficacy of a digital dietary self-monitoring (dDSM) log that uses positive reinforcement strategies (caregiver praise and gamification) to improve child engagement in DSM. The main aims were to:\n\n* Conduct a proof-of-concept trial that examines the effects of positive reinforcement on child DSM behaviors.\n* Explore differences in children's intrinsic motivation.\n\nParticipating children will be instructed to self-monitor their daily intake of targeted food groups (fruits, vegetables, sweet and salty snack foods, and sugar-sweetened beverages) for 4 weeks using a personal web-based DSM log. Each child-caregiver dyad will be randomly assigned to 1 of 4 conditions: BASIC, PRAISE, GAME, or PRAISE+GAME. For PRAISE and PRAISE+GAME conditions, caregivers will be instructed to provide daily process praise to their child related to DSM behaviors. For GAME and PRAISE+GAME conditions, logs will integrate three game mechanics: points, levels, and a virtual pet. Points will be accumulated for engaging in DSM behaviors, and accrual of points will evolve a virtual pet over time.", 'detailedDescription': 'The objective of the proposed study was to test the usability, acceptability, and preliminary efficacy of a digital dietary self-monitoring (dDSM) log that used positive reinforcement strategies (caregiver praise and gamification) to improve child engagement in DSM.\n\nFor this proof of concept trial, a mobile-optimized, web-based dDSM log was developed to test the two positive reinforcement strategies: caregiver praise and gamification. The dDSM log was developed as a mobile-optimized website, rather than an app, so that phone operating systems were not a limitation of use. Families were therefore able to access the dDSM log from a computer, smartphone, or other internet-enabled device. All dDSM logs included three basic features: 1) the ability to log targeted food groups with amounts and servings consumed, 2) the ability to indicate logging was complete for the day, and 3) access to a help feature that provided guidance on tracking and serving sizes. Children were instructed to self-monitor their daily intake of the following food groups: fruits, vegetables, sweet and salty snack foods, and sugar-sweetened beverages (SSBs). DSM focused on these four food groups because they had an established influence on health. Fruit and vegetable consumption was associated with a decreased risk of chronic disease, and reduced consumption of energy-dense foods like sweet and salty snacks and SSBs was recommended for weight loss in children. Additionally, these food groups were frequently targeted in childhood obesity treatment and were easily understood by young children.\n\nUsing a 2x2 factorial design, each child-caregiver dyad was randomly assigned to 1 of 4 conditions: BASIC, PRAISE, GAME, or PRAISE+GAME. Each child was provided a unique URL to access a personal dDSM log with the appropriate, randomly assigned features (praise and/or gamification). For PRAISE and PRAISE+GAME conditions, caregivers were instructed to provide daily process praise to their child related to DSM behaviors. While DSM was frequently implemented within treatment, children in the proposed study engaged in DSM without a concurrent intervention to tightly control the influence of the independent variables on DSM behaviors only (as compared to having all adult caregivers learn how to praise or having caregivers focus their praise on achieving dietary goals, which were both standard components of family-based childhood obesity interventions). Thus, only caregivers randomized to PRAISE or PRAISE+GAME were instructed on praise and, in the absence of dietary goals for intervention, caregivers had only one behavior (DSM) to praise. For GAME and PRAISE+GAME conditions, logs integrated three game mechanics: points, levels, and a virtual pet. Points were accumulated for engaging in DSM behaviors, and the accrual of points evolved a virtual pet over time, acting as a digital token economy. The number of points to level up increased with each level, so that each consecutive level was harder to attain than the previous one. At the end of the 4-week DSM period, families who completed follow-up assessments received two $25 gift cards (one for the caregiver, one for the child) and were provided access to a short online behavioral nutrition education program.\n\nThe primary DSM outcomes were frequency (i.e., the number of days any food/beverage item was tracked or logging was marked complete) and timing (i.e., how many sessions of recording were completed each day and whether foods/beverages were logged on the day of intake). On days in which no targeted food group was consumed, children had the ability to mark logging as complete for the day (Figure 1a). Indicating logging was complete in the absence of any tracked foods was considered a "tracked" day. Pre-post changes in intrinsic motivation were also examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Families with children ages 8-12 years with body mass index (BMI)-for-age ≥ 5th percentile who report eating foods/beverages (any serving size) from ≥2 targeted food groups (fruits, vegetables, sweet and salty snack foods, and SSBs) on ≥3 days/week each and who have an adult caregiver ≥18 years of age willing to participate\n* Family has reliable access to the internet via phone, computer, or another device that the child is able and permitted to operate\n\nExclusion Criteria:\n\n* Child has major psychiatric diseases or organic brain syndromes\n* Family does not live in the greater Knoxville area\n* Family does not speak English'}, 'identificationModule': {'nctId': 'NCT06193967', 'briefTitle': 'Enhancing Child Dietary Self-monitoring', 'organization': {'class': 'OTHER', 'fullName': 'The University of Tennessee, Knoxville'}, 'officialTitle': 'Enhancing Child Digital Dietary Self-monitoring: Proof-of-concept Trial', 'orgStudyIdInfo': {'id': 'UTK IRB-23-07903-XP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'BASIC', 'description': "Children will be asked to track their intake of fruits, vegetables, sweet and salty snack foods, and sugary drinks in the web-based dietary self-monitoring (DSM) log for 4 weeks. Each child will be provided with a personal URL to access their log, which can be accessed from any internet-capable device (computer, phone, etc.). Caregivers will be asked to review their child's log each day and complete a caregiver check-in in the DSM log."}, {'type': 'EXPERIMENTAL', 'label': 'PRAISE', 'description': 'In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in.', 'interventionNames': ['Behavioral: Caregiver Praise']}, {'type': 'EXPERIMENTAL', 'label': 'GAME', 'description': "In addition to the conditions of the BASIC group, the child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.", 'interventionNames': ['Behavioral: Gamification']}, {'type': 'EXPERIMENTAL', 'label': 'PRAISE+GAME', 'description': "In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in. The child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.", 'interventionNames': ['Behavioral: Caregiver Praise', 'Behavioral: Gamification']}], 'interventions': [{'name': 'Caregiver Praise', 'type': 'BEHAVIORAL', 'description': "Caregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement", 'armGroupLabels': ['PRAISE', 'PRAISE+GAME']}, {'name': 'Gamification', 'type': 'BEHAVIORAL', 'description': "DSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors", 'armGroupLabels': ['GAME', 'PRAISE+GAME']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37996', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Tennessee, Knoxville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Associate Dean of Research & Operations, College of Education, Health, and Human Sciences', 'investigatorFullName': 'Hollie Raynor', 'investigatorAffiliation': 'The University of Tennessee, Knoxville'}}}}